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Valutazione di un modello differenziato di ricerca e gestione attiva dei casi presso il punto di cura per eliminare la trasmissione dell'HIV da madre a figlio in Malawi (PAC-Man)

17 settembre 2026 aggiornato da: University of North Carolina, Chapel Hill

UNCPM 22401 - Valutazione di un modello differenziato di ricerca e gestione attiva dei casi presso il punto di cura per l'eliminazione della trasmissione dell'HIV da madre a figlio a Lilongwe e Mangochi, Malawi

Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:

  1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing.
  2. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing.
  3. Compare implementation outcomes between the PAC-Man model and SOC.

Participants: The total study sample size is 2,426, including 2,304 mother-infant pair (MIP) survey participants, 48 high-risk pregnant/breastfeeding women living with HIV for in-depth interviews (from high-risk MIPs who participated in a survey); 10 PMTCT policy makers and Ministry of Health (MOH)/ President's Emergency Plan for AIDS Relief (PEPFAR) implementing partner senior managers for key informant interviews; and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys.

To rigorously evaluate the PAC-Man model, investigators will use a hybrid (type 3) effectiveness-implementation incomplete stepped-wedge trial design. The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental "rollout" of the PAC-Man model and serial measurement of both health outcomes (for infants and mothers in Objectives 1 and 2, respectively), as well as implementation outcomes (Objective 3). The incomplete stepped-wedge design is more efficient than a complete design, minimizes costs, and reduces participant burden, without sacrificing statistical precision. Using this design, sequential crossover from control (i.e., the SOC) to intervention (i.e., SOC plus the PAC-Man model) takes place at each 'step' using cluster randomization until all clusters (defined as a group of "sites," or health facilities plus the surrounding communities in its catchment area) receive the intervention. The 12 sites included in our study will be divided into 4 clusters of 3 sites each.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PAC-Man Model:

PAC-Man represents an integrated differentiated services delivery (DSD) model for mothers and infants that brings the following three evidence-based practices into the community for elimination of mother to child transmission (EMTCT): 1) pediatric active case finding using novel point-of-care (POC) early infant diagnosis (EID) technology; 2) same-day antiretroviral therapy (ART) initiation for infants newly diagnosed with HIV infection; and 3) maternal viral load (mVL) testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs in which the mother living with HIV did not initiate ART, started ART late during pregnancy or breastfeeding, dropped off treatment following ART initiation, was unsuppressed on ART, was identified with HIV infection for the first-time during the post-partum period, and/or did not return with her infant for EID testing. Because these evidence-based practices are already recommended by the Ministry of Health and will be functioning at the site and not the individual level, delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA™ in community settings.

PAC-Man Implementation Approaches:

The overall implementation strategy being evaluated in this study is the creation of mobile care teams to deploy m-PIMA™ and provide EMTCT services in the community. Complementing this overarching strategy will be two sub-strategies used to enhance PAC-Man adoption: 1) task shifting of active case finding, EID and mVL testing, ART initiation, and back-to-care services to community health workers (CHWs), community nurses, and HIV diagnostic assistants; and 2) changing service sites to convenient locations in the community to overcome barriers to EID and mVL delivery. These strategies are intended to work in concert with the above evidence-based practices to integrate PAC-Man into the EMTCT program.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2426

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Malawi
      • Lilongwe, Malawi
        • Reclutamento
        • Area 18 Health Centre
        • Contatto:
      • Monkey Bay, Malawi
        • Reclutamento
        • Monkey Bay Community Hospital
        • Contatto:
    • Central Region
      • Lilongwe, Central Region, Malawi
        • Non ancora reclutamento
        • Bwaila Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

The criteria for Enumerated MIP Cohort is as follows:

Inclusion Criteria:

  • Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.

Exclusion Criteria:

  • None.

The criteria for Enumerated MIP Field Survey is as follows:

Inclusion Criteria:

  • Age 16 years or older.
  • Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.

Exclusion Criteria:

  • Documented transferred out from a site prior to the field survey.
  • Participated previously in the field survey.
  • Decline informed consent.

The criteria for In-Depth Interviews is as follows:

Inclusion criteria:

  • Age 16 years or older.
  • Met high-risk criteria for PAC-Man model.
  • Participated in a field survey.

Exclusion criteria:

  • Decline informed consent.

The criteria for Focus Group Discussions is as follows:

Inclusion criteria:

  • Age 18 years or older.
  • MOH or implementing partner professional or lay health worker at a study site (such as nurses, community health workers, health surveillance assistants, and HIV diagnostic assistants)
  • Generally familiar with the PAC-Man model and/or EMTCT/ EID service delivery at their site.

Exclusion criteria:

  • Decline informed consent.

The criteria for Key Informant Interviews is as follows:

Inclusion criteria:

  • Age 18 years or older.
  • HIV/ EMTCT policy maker OR MOH/ PEPFAR implementing partner senior manager.
  • Generally familiar with HIV and/or EMTCT/ EID service delivery.

Exclusion criteria:

  • Decline informed consent.

The criteria for Implementation Actor Questionnaires is as follows:

Inclusion criteria:

  • Age 18 years or older.
  • Professional or lay health provider at a study site.
  • Generally familiar with HIV and/or EMTCT/ EID service delivery at their site.
  • Participated in a focus group discussion.

Exclusion criteria:

  • Decline informed consent.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PAC-Man Model

PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) mVL testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs. Delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings.
Comportamentale: PAC-Man

PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) mVL testing and back-to-care services. PAC-Man uses a mobile approach to offer EMTCT services in the community and reach "high risk" MIPs. Delivering the PAC-Man model will be done under the auspices of routine care, applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings.
Comparatore attivo: Standard of care (control arm)

Routine care as provided by the Ministry of Health.
Comportamentale: Standard of Care

Routine care as provided by Ministry of Health.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of infants who receive EID testing by age 6 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants exposed to HIV who receive EID testing by age 6 months among the enumerated cohort of MIPs with infants at least 6 weeks old at all study sites.
Within 12 months of MIP enrollment in the national EMTCT program

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of infants who receive EID testing by age 2 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants exposed to HIV who receive EID testing by age 2 months among the enumerated cohort of all MIPs with infants at least 6 weeks old at all study sites.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who receive EID testing by age 12 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants exposed to HIV who receive EID testing by age 12 months among the enumerated cohort of all MIPs with infants at least 6 weeks old at all study sites.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk infants who receive EID testing by age 6 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants with high-risk mothers exposed to HIV who receive EID testing by age 6 months among all high-risk MIPs with infants at least 6 weeks old at all study sites.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants newly diagnosed with HIV who initiate ART ≤60 days from EID sample collection among the enumerated cohort of all infants.
Within 12 months of MIP enrollment in the national EMTCT program
Median infant results return time
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Median number of days from infant EID sample collection to results returned to caregivers.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants newly diagnosed with HIV
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants newly diagnosed with HIV among the enumerated cohort of all infants.
Within 12 months of MIP enrollment in the national EMTCT program
Median age at ART initiation among infants
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Median age in months at ART initiation among infants who test positive for HIV.
Within 12 months of MIP enrollment in the national EMTCT program
Median time to ART initiation among infants
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Median number of days to ART initiation among infants who test positive for HIV.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART the same day as diagnosis
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants newly diagnosed with HIV who initiate ART on the same day as EID results received among the enumerated cohort of all infants.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants with HIV retained in care at 3 months post-ART initiation
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants with HIV who are retained in care at 3-months post-ART initiation.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants with HIV retained in care at 6 months post-ART initiation
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants with HIV who are retained in care at 6-months post-ART initiation.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs reached with viral load testing
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers living with HIV who received MOH-recommended 6-monthly VL testing during pregnancy and breastfeeding among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs reached with viral load testing
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of high-risk MIPs living with HIV who received MOH-recommended 6-monthly VL testing during pregnancy and breastfeeding among all high-risk MIPs from the enumerated cohort.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 6 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers with viral suppression (<1,000 copies of HIV per ml.) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 6 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of high-risk mothers with viral suppression (<1,000 copies of HIV per ml.) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 12 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers with viral suppression (<1,000 copies of HIV per ml.) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 12 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of high-risk mothers with viral suppression (<1,000 copies of HIV per ml.) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 6 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers who are retained in care (≥1 clinic encounter within the last 180 days) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 12 months
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers who are retained in care (≥1 clinic encounter within the last 180 days) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who resumed ART
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of mothers who had documented treatment interruption (i.e., a treatment gap ≥28 days) who later resumed ART among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who received enhanced adherence counseling
Lasso di tempo: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of MIPs who had unsuppressed viral load and then completed enhanced adherence counselling among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Adoption - proportion of sites that adopt the PAC-Man model
Lasso di tempo: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)

Number of trained sites that deliver the PAC-Man intervention divided by the total number of trained sites. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
Adoption - proportion of providers who adopt the PAC-Man model
Lasso di tempo: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)

Number of trained providers who deliver the PAC-Man intervention divided by the total number of trained providers. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
Implementation - cost per pediatric case
Lasso di tempo: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)

Incremental cost of PAC-Man implementation per pediatric HIV case identified, compared to standard of care. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
Implementation - cost per unsuppressed MIP
Lasso di tempo: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)

Incremental cost of PAC-Man implementation per pregnant and breastfeeding woman with unsuppressed viral load identified, compared to standard of care. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigatori

  • Investigatore principale: Michael Herce, MD, MPH, University of North Carolina, Chapel Hill

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 marzo 2025

Completamento primario (Stimato)

31 marzo 2028

Completamento dello studio (Stimato)

31 marzo 2028

Date di iscrizione allo studio

Primo inviato

26 giugno 2024

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2024

Primo Inserito (Effettivo)

10 luglio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 24-0561
  • 1P01HD112215 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).

Periodo di condivisione IPD

Beginning 9 and continuing for 36 months following publication

Criteri di accesso alla condivisione IPD

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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